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Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation (REVERSE-MR)

Primary Purpose

Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgery
Clinical interview and echocardiography
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Asymptomatic patients according history or an exercise test in those able to perform it if there is a doubt about the absence of symptoms
  • Severe (grade IV) degenerative MR due to leaflet prolapse assessed by echocardiography
  • LV ejection fraction by Simpson biplane method ≥60% and LV end-systolic diameter by TM echocardiography ≤40mm
  • Sinus rhythm on the inclusion ECG
  • Pulmonary artery pressure ≤50 mmHg by Doppler echocardiography.
  • High probability of mitral valve repair
  • EuroSCORE II ≤ 3%

Exclusion Criteria:

  • Mitral stenosis or > mild aortic valve disease (stenosis or regurgitation)
  • Congenital heart disease (except patent foramen ovale or atrial septal defect)
  • Patients with cardiac prostheses
  • Previous myocardial infarction
  • Previous cardiac surgery
  • Extra cardiac comorbidity with life expectancy < 5 years
  • Recent history of psychiatric disease (including drug or alcohol abuse)
  • Therapy with an investigational intervention at the time of screening or plan to enrol patient in additional intervention study during participation in this trial

Sites / Locations

  • CHU Amiens-PicardieRecruiting
  • Centre Cardiologique du NordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early mitral valve repair

Conservative management

Arm Description

Surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months and afterwards yearly until the end of follow-up. Echocardiography will be performed at discharge, at 6 months and at the end of follow-up.

Patients will be followed up by clinical interview and echocardiography every 6 months.

Outcomes

Primary Outcome Measures

death and occurrence of adverse cardiovascular events
Time from randomization to the first occurrence of one of the following composite end-point including all-cause death and occurrence of adverse cardiovascular events (heart failure, atrial fibrillation, infective endocarditis, cerebrovascular events).

Secondary Outcome Measures

Full Information

First Posted
December 26, 2017
Last Updated
June 6, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03389542
Brief Title
Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
Acronym
REVERSE-MR
Official Title
Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be surgically repaired in the vast majority of patients. Despite the efficacy of mitral valve repair, an ongoing international controversy exists regarding the need to perform early surgery in asymptomatic patients with severe MR and no sign of LV dysfunction in whom the probability of successful and durable repair is very high. In this group of patients, differing views of the risks of uncorrected severe MR exist: considered as benign by those supporting medical "watchful waiting" or associated with significant excess mortality/morbidity by those advocating early surgery. This controversy can only be resolved by a randomized controlled trial which is still lacking. The main objective is to demonstrate the superiority of early mitral valve repair in patients with asymptomatic severe MR due to leaflet prolapse compared to an initial conservative management in terms of all-cause death and cardiovascular morbidity during five years follow-up.
Detailed Description
Experimental group: In patients randomized to early mitral valve repair, surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months and afterwards yearly until the end of follow-up. Echocardiography will be performed at discharge, at 6 months and at the end of follow-up. Control group: Patients randomized to initial conservative management will be followed up by clinical interview and echocardiography every 6 months. Patients will be instructed to report any change in functional status in a prompt manner. Surgery will be indicated at the onset of symptoms or if one or more of the following occur during follow-up: LV end-systolic diameter >40mm, LV ejection fraction <60%, recurrent atrial fibrillation, or resting systolic pulmonary artery pressure >50mmHg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early mitral valve repair
Arm Type
Experimental
Arm Description
Surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months and afterwards yearly until the end of follow-up. Echocardiography will be performed at discharge, at 6 months and at the end of follow-up.
Arm Title
Conservative management
Arm Type
Active Comparator
Arm Description
Patients will be followed up by clinical interview and echocardiography every 6 months.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Early mitral valve repair
Intervention Type
Other
Intervention Name(s)
Clinical interview and echocardiography
Intervention Description
Clinical interview and echocardiography every 6 months.
Primary Outcome Measure Information:
Title
death and occurrence of adverse cardiovascular events
Description
Time from randomization to the first occurrence of one of the following composite end-point including all-cause death and occurrence of adverse cardiovascular events (heart failure, atrial fibrillation, infective endocarditis, cerebrovascular events).
Time Frame
during 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asymptomatic patients according history or an exercise test in those able to perform it if there is a doubt about the absence of symptoms Severe (grade IV) degenerative MR due to leaflet prolapse assessed by echocardiography LV ejection fraction by Simpson biplane method ≥60% and LV end-systolic diameter by TM echocardiography ≤40mm Sinus rhythm on the inclusion ECG Pulmonary artery pressure ≤50 mmHg by Doppler echocardiography. High probability of mitral valve repair EuroSCORE II ≤ 3% Exclusion Criteria: Mitral stenosis or > mild aortic valve disease (stenosis or regurgitation) Congenital heart disease (except patent foramen ovale or atrial septal defect) Patients with cardiac prostheses Previous myocardial infarction Previous cardiac surgery Extra cardiac comorbidity with life expectancy < 5 years Recent history of psychiatric disease (including drug or alcohol abuse) Therapy with an investigational intervention at the time of screening or plan to enrol patient in additional intervention study during participation in this trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe TRIBOUILLOY, MD, phD
Phone
322 087 250
Ext
0033
Email
tribouilloy.christophe@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe TRIBOUILLOY, MD, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Cardiologique du Nord
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas GOISSEN
Phone
01 49 33 41 38
Ext
0033
Email
thomas.goissen@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation

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